EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/640/2023 ANNEX  
(POOL/E4/2023/640/640 -EN 
ANNEX.docx)  
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
approving reaction mass of N,N -didecyl -N-(2-hydroxyethyl) -N-methylammonium 
propionate and N,N -didecyl -N-(2-(2-hydroxyethoxy)ethyl) -N-methylammonium 
propionate and N,N -didecyl -N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl) -N-
methylammonium propionate as an active substance for use in biocidal products of 
product -types 2 and 4 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council    
EN 1  EN ANNEX  
Common Name  IUPAC Name  
Identification 
Numbers  Minimum degree of purity 
of the active substance1 Date of 
approval  Expiry 
date of 
approval  Product 
type Specific conditions  
reaction mass of 
N,N-didecyl -N-
(2-
hydroxyethyl) -N-
methylammoniu
m propionate and 
N,N-didecyl -N-
(2-(2-
hydroxyethoxy)e
thyl) -N-
methylammoniu
m propionate and 
N,N-didecyl -N-
(2-(2-(2-
hydroxyethoxy)e
thoxy)ethyl) -N-
methylammoniu
m propionate  
(‘DMPAP’)  reaction mass of 
N,N-didecyl -N-(2-
hydroxyethyl) -N-
methylammonium 
propionate and N,N -
didecyl -N-(2-(2-
hydroxyethoxy)ethyl
)-N-
methylammonium 
propionate and N,N -
didecyl -N-(2-(2-(2-
hydroxyethoxy)etho
xy)ethyl) -N-
methylammonium 
propionate  
EC No: - 
CAS No: - 86,1% w/w dry weight  
 
  1 February 
2025 31 January  
2035 2 The authorisation of biocidal products is subject to the 
following condition s: 
(a) the product assessment pay s particular attention to the 
exposures, the risks and the efficacy linked to any 
uses covered by an application for authorisation, but 
not addressed in the Union -level risk assessment of 
the active substance;  
(b) the product assessment  pays particular att ention to:  
(i) professional users ; 
(ii) environment: groundwater . 
4 The authorisation of biocidal products is subject to the 
following condition s: 
(a) the product assessment pay s particular attention to the 
exposures, the risks and the efficacy linked to any uses covered 
by an application for authorisation, but not addressed in the 
Union -level risk assessment of the active substance;  
(b) the product assessment pay s particular att ention to:  
(i) professional users ; 
                 (ii) environment: groundwater.  
(c) for products that may lead to residues in food or feed, it 
shall be assessed whether new maximum residue levels 
(MRLs) need to be set or the existing MRLs need to be 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to  the evaluated active substance.    
EN 2  EN amended in accordance with Regulation (EC) No 470/2009  of 
the European Parliament and of the Council2 or Regulation 
(EC) No 396/2005  of the European Parliament and of the 
Council3, and any appropriate risk mitigation measures shall be 
taken to ensure that such MRLs are not exceeded ; 
(d) products containing DMPAP are not incorporated in 
materials and articles intended to come into contact with food 
that falls within the scope of Regulation (EC) No 1935/2004 of 
the European Parliament and of the Council4, unless the 
Commission has established specific limits on the migration of 
DMPAP into food or it has been established pursuant to that 
Regulation that such limits are not necessary.  
 
                                                 
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regul ation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Co uncil (OJ L 152, 16.6.2009, p. 11).  
3 Regulation (EC) No 396/2005 of the Europea n Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
4 Regulation (EC) No  1935 /2004 of the Europe an Parliament and of the Council of 27 October  2004 on materials and articles intended to come into contact with food and 
repealing Directives 80/590/EEC and 89/109/EEC  (OJ L 338, 13.11.2004, p. 4).